DaxibotulinumtoxinA (Daxxify) is used in adults to temporarily lessen the appearance of facial wrinkles.

DaxibotulinumtoxinA (Daxxify) may also be used for purposes not listed in this medication guide.

The botulinum toxin contained in daxibotulinumtoxinA (Daxxify) can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

DaxibotulinumtoxinA (Daxxify) injections should be given only by a trained medical professional, even when used for cosmetic purposes.

DaxibotulinumtoxinA (Daxxify) is injected into a muscle by a healthcare provider. DaxibotulinumtoxinA (Daxxify) injections should be spaced at least 3 months apart.

Your doctor may occasionally change your dose until your doctor determine the best dose.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medicine more often than prescribed will not make it more effective and may result in serious side effects.

Usual Adult Dose for Glabellar Lines:

Inject 8 units (0.1 mL) intramuscularly into each of 5 sites (two injections in each corrugator muscle and one injection in the procerus muscle) for a total dose of 40 units.

Comments:
-Refer to manufacturer information for specific administration instructions including dilution, needle orientation, and injection site diagrams.
-The safety and effectiveness of dosing more frequently than every 3 months have not been clinically evaluated.

Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

You should not receive daxibotulinumtoxinA (Daxxify) if you have an infection in the area where the medicine will be injected or are allergic to botulinum toxin or to any other botulinum toxin injection, such asrimabotulinumtoxinB (MYOBLOC), onabotulinumtoxinA (BOTOX, BOTOX COSMETIC), abobotulinumtoxinA (DYSPORT), incobotulinumtoxinA (XEOMIN) or prabotulinumtoxinA-xvfs (JEUVEAU).

Tell your doctor if you have or ever had:

• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

• myasthenia gravis;

• Lambert-Eaton syndrome;

• a side effect after prior use of botulinum toxin;

• a breathing disorder such as asthma or emphysema;

• problems with swallowing;

• heart problems;

• bleeding problems;

• facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);

• dry eyes after receiving botulinum toxin in the past;

• a planned surgery;

• surgery on your face; or

• received other botulinum toxin injection in the past 4 months.

It is not known whether daxibotulinumtoxinA (Daxxify) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Since DaxibotulinumtoxinA (Daxxify) has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, weak or shallow breathing, or loss of movement in any part of your body.

DaxibotulinumtoxinA (Daxxify) may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in daxibotulinumtoxinA (Daxxify) can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these side effects (up to several hours or several weeks after an injection):

• hoarse voice, trouble breathing, talking, or swallowing;

• vision changes, eye pain, blurred vision, drooping eyelids, severely dry or irritated eyes (your eyes may be more sensitive to light);

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

• chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats; or

• loss of bladder control.

Common side effects of daxibotulinumtoxinA may include:

• drooping eyelids;

• headache; or

• loss of the ability to move the muscles in the face.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• an antibiotic such as amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin;

• a muscle relaxer;

• inhaled anesthetics;

• bronchodilator asthma medication;

• cold or allergy medicine (Benadryl and others);

• medicine to treat overactive bladder;

• medicine to treat Parkinson's disease;

• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome; or

• seizure medicine.

This list is not complete and many other drugs may affect daxibotulinumtoxinA (Daxxify). This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.